Sleep Disorder
Conditions
Interventions
Trial group:Dalirese treatment for 4 weeks
Control group:Estazolam 0.5mg, treatment for 4 weeks
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Diagnostic criteria for HCC: (1) Voluntarily join this study and sign the informed consent form; (2) Age 18–75 years, male or female; (3) Confirmed diagnosis of HCC by histopathology, cytology, or in cirrhotic patients according to AASLD criteria, with no limitation on tumor stage (BCLC stage 0–C); for BCLC stage C patients, absence of extrahepatic metastasis is required; (4) Child-Pugh score =6 months. 2. Diagnostic criteria for sleep disorder: (1) Meet DSM-5 criteria for chronic insomnia: in the presence of adequate sleep opportunity, difficulty initiating sleep (sleep latency >30 min), difficulty maintaining sleep (wake after sleep onset >30 min), or early morning awakening (awakening >=30 min earlier than desired), occurring >=3 times per week for >=3 months, accompanied by daytime functional impairment (including but not limited to: fatigue/lack of energy, attention/memory decline, mood instability/irritability, daytime sleepiness, or persistent worry about sleep); (2) Insomnia Severity Index (ISI) total score >=15 at screening (i.e., moderate or severe insomnia); (3) Have basic communication and comprehension abilities to complete sleep scale assessments and follow-up. 3. Treatment and medication status: (1) Receiving or planning to receive liver cancer-related treatments (including but not limited to surgery, TACE, targeted therapy, immunotherapy, etc.); (2) Stable general condition, with laboratory parameters meeting the following requirements within 7 days before enrollment: Hematology (except hemoglobin, without blood transfusion or use of granulocyte colony-stimulating factor [G-CSF] or other cytokine-based agents within 2 weeks before screening): 1) Absolute neutrophil count >=1.5×10^9/L; 2) Platelet count >=75×10^9/L; 3) Hemoglobin >=90 g/L; Biochemistry: 4) Serum albumin >=28 g/L (without albumin infusion within 14 days before screening); 5) Total serum bilirubin 50 mL/min (by Cockcroft-Gault formula): Male: Cr clearance = ((140 – age) × weight) / (72 × serum Cr) Female: Cr clearance = ((140 – age) × weight) / (72 × serum Cr) × 0.85 (weight in kg; serum Cr in mg/mL); 8) INR =2+, a 24-hour urine protein quantification may be performed; 24-hour urine protein <1.0 g is acceptable for enrollment).
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria must be excluded from the study: 1. Specific liver complications: (1) A prior or current definite diagnosis of hepatic encephalopathy (grade II or above), or acute episode during the study period; (2) Active upper gastrointestinal massive bleeding or other life-threatening hepatic decompensation; (3) Clinically uncontrollable ascites or pleural effusion. 2. Other possible physical diseases or other types of sleep disorders: (1) Moderate-to-severe obstructive sleep apnea syndrome (OSA), narcolepsy, moderate-to-severe restless legs syndrome, or circadian rhythm sleep-wake disorder; (2) Although laboratory parameters meet the criteria, the investigator judges that the patient has unstable or inadequately treated severe cardiovascular (e.g., unstable angina, severe arrhythmia, etc.), renal, or neurological diseases (e.g., epilepsy, Parkinson's disease, cognitive impairment, acute phase of stroke, etc.) that may increase subject risk or interfere with efficacy assessment. 3. Severe mental disorders: (1) Definite diagnosis of schizophrenia spectrum disorders, manic phase of bipolar disorder, or history of substance dependence or abuse; (2) Current acute suicide risk requiring priority psychiatric intervention. 4. Drug-related exclusion criteria: (1) Participation in another drug clinical study within 4 weeks before enrollment; (2) Medical conditions affecting the absorption, distribution, metabolism, or excretion of the study drug; (3) Known allergy to daridorexant or any of its excipients; (4) Use of strong CYP3A4 inhibitors or inducers within 2 weeks before the study, and unable to discontinue; (5) Long-term, high-dose use of benzodiazepines or Z-drugs, and unable to adjust the regimen in the short term. 5. Other conditions: (1) Pregnancy or breastfeeding; (2) Another active malignancy other than HCC within 5 years or concurrently; (3) Poor prior compliance as judged by the investigator; (4) Expected inability to complete follow-up (e.g., transfer to another hospital in the short term, high risk of loss to follow-up); (5) Other conditions that the investigator considers unsuitable for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate defined as a decrease of >=6 points in ISI score from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in total ISI score;Change in PSQI score;Change in QoL scale score;Change in anxiety and depression scale scores;Changes in inflammatory markers;Changes in neurotransmitter levels; | — |
Countries
China
Contacts
Public ContactHuang Xiao
Zhongshan Hospital, Fudan University
Outcome results
None listed